Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Dermatologic reactions
Patients receiving mogamulizumab have experienced drug rash (drug eruption), some of which were severe and/or serious.

When mogamulizumab has been administered to patients with T-cell lymphomas other than MF or SS, serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in less than 1% of patients during clinical trials, and also reported during the post-marketing period; some of these cases were reported with fatal outcomes. Patients should be closely monitored for symptoms or signs that suggest SJS or TEN. If they occur, POTELIGEO should be interrupted and treatment should not restart unless SJS or TEN is ruled out and cutaneous reaction has resolved to Grade 1 or less. If SJS/TEN occur, appropriate medical therapy should be administered. See section 4.2 for dose modification information.

Infusion-related reactions
Acute infusion-related reactions (IRRs) have been observed in patients treated with mogamulizumab.
The IRRs were mostly mild or moderate in severity, although there have been a few reports of severe reactions (Grade 3). The majority of IRRs occur during or shortly after the first infusion (all within 24 hours of administration), with the incidence decreasing over subsequent treatments.

Patients should be carefully monitored during and after infusion. If an anaphylactic reaction occurs, administration of mogamulizumab should be immediately and permanently discontinued and appropriate medical therapy should be administered.

If an IRR occurs, the infusion should be interrupted and appropriate medical management instituted.
The infusion may be restarted at a slower rate after symptom resolution. See section 4.2 for pre- medication and dose modification information.

Infections
Subjects with MF or SS treated with mogamulizumab are at increased risk of serious infection and/or viral reactivation. The combination of mogamulizumab with systemic immune modulating medicinal products or with other licensed therapies for MF or SS has not been studied and is, therefore, not recommended, especially in consideration of the risk of severe infections in patients treated with mogamulizumab. Topical steroids or low doses of systemic corticosteroids may be used during treatment with mogamulizumab; however, the risk of serious infection and/or viral reactivation may be higher in case of concomitant administration with systemic immunosuppressive agents. Patients should be monitored for signs and symptoms of infection and treated promptly.

Patients should be tested for hepatitis B infection before initiating treatment with mogamulizumab. For patients who test positive for current/previous hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended for advice concerning appropriate measures against hepatitis B reactivation.

Complications of allogeneic hematopoietic stem cell transplantation (HSCT) after mogamulizumab Complications, including severe graft versus host disease (GVHD), have been reported in patients with T-cell lymphomas other than MF or SS who received allogeneic HSCT after mogamulizumab.

A higher risk of transplant complications has been reported if mogamulizumab is given within a short time frame (approximately 50 days) before HSCT. Follow patients closely for early evidence of transplant-related complications.

The safety of treatment with mogamulizumab after autologous or allogeneic HSCT has not been studied.

Tumour lysis syndrome
Tumour lysis syndrome (TLS) has been observed in patients receiving mogamulizumab. TLS was observed most frequently during the first month of treatment. Patients with rapidly proliferating tumour and high tumour burden are at risk of TLS. Patients should be monitored closely by appropriate laboratory and clinical tests for electrolyte status, hydration and renal function, particularly in the first month of treatment, and managed according to best medical practice. Management of TLS may include aggressive hydration, correction of electrolyte abnormalities, anti-hyperuricaemic therapy, and supportive care.

Cardiac disorders
One case of acute myocardial infarction has been observed in a clinical trial patient with MF / SS receiving mogamulizumab. In clinical trial patients with other T-cell lymphomas there have been reports of stress cardiomyopathy (one case) and acute myocardial infarction (one case). The subjects had a medical history including various risk factors. Patients who have risk factors associated with cardiac disease should be monitored and appropriate precautions taken.

Large cell transformation (LCT)
There are limited data available on patients with LCT.

Other
Mogamulizumab should not be administered subcutaneously or intramuscularly, by rapid intravenous administration, or as an intravenous bolus.

This medicinal product contains less than 1 mmol sodium per dose, that is to say essentially ‘sodium free’.

Effects on Driving

4.7   Effects on ability to drive and use machines

Mogamulizumab has minor influence on the ability to drive and use machines. Fatigue may occur following administration of mogamulizumab (see section 4.8).